ACCP Update: The Clinical Pharmacist as Principal Investigator American College of Clinical Pharmacy Michael E. Burton, Pharm.D, Mark A. Munger, Pharm.D., FCCP, FACC, Edward M. Bednarczyk, Pharm.D., FCCP, Lisa E. Davis, Pharm.D., George A. Davis Pharm.D., Mary E. Elliott, Pharm.D., Ph.D., Julie Oki Maurey, Pharm.D., FCCP Terry L. Seaton, Pharm.D., FCCP, Daniel R. Touchette, Pharm.D., M.A., and Jennifer Zimmer-Young, Pharm.D., CCRP This paper summarizes the history of the clinical pharmacist as a principal investigator across a wide range of research venues and disciplines. Clinical pharmacists have served as principal investigators on a wide range of grants and contracts from all available funding sources, including peer-reviewed funding from the National Institutes of Health (NIH). The NIH Conference on Pharm.D. Pathways to Biomedical Research in 2006 (http://www.nigms.nih.gov/ Training/PharmD/) is a strong endorsement of current and future opportunities for clinical pharmacist–directed research. Both research funding and resultant scholarship have increased during the past decade, primarily in academic settings. Through an American Association of Colleges of Pharmacy database, the number of faculty with a Pharm.D. as their terminal degree who received NIH funding increased from 5 in 1998 to 24 in 2007. Use of www.ClinicalTrials.gov provided a stronger picture of clinical pharmacist research, with 523 studies performed by those with a Pharm.D. degree when searched in 2009. Because of the lack of a central database, it is difficult to discern the true number and extent of clinical pharmacist research funding and scholarship. Scientific efforts are still required to completely understand the impact of research and scholarship by clinical pharmacists. Most important, clinical pharmacist development needs to be an academic and practice priority to ensure an adequate supply of clinical pharmacists as principal investigators to continue making substantial and meaningful contributions in meeting the needs of patients, improving public health, and expanding the roles of clinical pharmacists. Key Words: clinical pharmacist, principal investigator, faculty development, research funding, pharmacist roles (Pharmacotherapy 2010;30(12):485e–89e)
The role of the clinical pharmacist as principal investigator (PI) was first described in a commentary by the American College of Clinical Pharmacy (ACCP) in 2000.1 From 2000 to the present, the number of individuals with the doctor of pharmacy (Pharm.D.) as a terminal degree who have served as PIs has grown.
Clinical pharmacists have served as PIs either by directing their own investigator-initiated research or by working within sponsored clinical trials. Moreover, a small but increasing number of clinical pharmacists have been funded by the National Institutes of Health (NIH). The NIH has strongly endorsed the role of the
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clinical pharmacist as an investigator. In 2006, the NIH held a conference titled “Pharm.D. Pathways to Biomedical Research” to promote the expansion of NIH-funded clinical pharmacists.2 Today, pharmacists are widely accepted as PIs by foundations, industry, and government.2–8
IRB/IEC, and/or the regulatory authority(ies).11, 12 This statement is consistent with federal regulations as described Section 312.53 of the 5/1/2003 Code of Federal Regulations (21CFR312), Chapter 1 FDA, Part 312, on the role of PIs.11, 12
History of the Clinical Pharmacist as PI: The Past 10 Years
Evidence Supporting the Pharm.D. as PI
In 1975, the Millis Study Commission on Pharmacy definitively stated that the “clinical scientist” is an individual equally skilled and trained in the science and practice of pharmacy, setting the stage for the widespread development of postgraduate fellowship training programs.9 Recognition first came in May 1983 by Stuart L. Nightingale, M.D., then-U.S. Food and Drug Administration (FDA) Associate Commissioner for Health Affairs, who stated, “It has long been FDA policy to accept Doctors of Pharmacy as principal investigators of studies of investigational drugs within their expertise.”10 In 1990, recognition of the clinical scientist was reestablished and described in the original ACCP commentary, “The Clinical Pharmacist as a Principal Investigator,” setting the foundation for the expansion of pharmacist-directed research.1 Several documents or regulations support Pharm.D.s or clinical pharmacists as PIs across a range of research types. The FDA and European Medicines Agency provide consolidated guidance to industry according to Good Clinical Practice, stating: The investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirement(s), and should provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor, the This document is from the 2009 Publications Committee: Michael E. Burton, Pharm.D, (Chair); Mark A. Munger, Pharm.D., FCCP, FACC (Vice-chair); Edward M. Bednarczyk, Pharm.D., FCCP; Lisa E. Davis, Pharm.D.; George A. Davis Pharm.D., BCPS; Mary E. Elliott, Pharm.D., Ph.D.; Julie Oki Maurey, Pharm.D., FCCP, BCPS; Terry L. Seaton, Pharm.D., FCCP, BCPS; Daniel R. Touchette, Pharm.D., MA; and Jennifer Zimmer-Young, Pharm.D., CCRP. Approved by the American College of Clinical Pharmacy Board of Regents on April 22, 2010 Address reprint requests to the American College of Clinical Pharmacy, 13000 W. 87th St. Parkway, Suite 100, Lenexa, KS 66215; e-mail:
[email protected]; or download from http://www.accp.com.
In the past 3 decades, there has been a substantial increase in pharmacist-directed research, as evidenced by the growth in funded grants and scientific publications. Pharmacists have served as PIs for a wide variety of grants and contracts from all available funding sources, including the NIH, the FDA, the Agency for HealthCare Research and Quality, the Department of Veteran Affairs and other federal departments, state and local governments, private organizations and foundations, and the pharmaceutical industry.13 Increased NIH Funding of Pharmacists Although the NIH does not provide a complete listing of clinical pharmacists who have been funded as PIs, the American Association of Colleges of Pharmacy (AACP) tracks NIH funding for colleges of pharmacy. AACP has worked diligently to differentiate Pharm.D.trained faculty from others and has provided a listing of NIH-funded faculty since 1998 (Kenneth Miller, personal communication, 2009). Specifically, five individuals with a Pharm.D. as their terminal degree were funded in 1998. By contrast, a minimum of 24 were funded in 2007. Types of funding ranged from the R to the K and U series of grants. These data do not include notable NIH-funded pharmacists working in institutes, foundations, research hospitals, or similar institutions. Thus, the total number of Pharm.D.s who have received NIH funding as PIs is likely higher. From 1996 to 2003, funding from the NIH for colleges of pharmacy as a whole increased by 123%. This increase was primarily because of the increased amounts awarded, not the number of awards. The greatest percent increase was in social and administrative (from about 2% to 3%) and pharmacy practice (from less than 1% to about 1.5%) faculty. Nonetheless, NIH funding remains modest, with only 1.15% of pharmacy practice faculty having received an NIH grant, despite an increase in the absolute number of practice faculty. Pharmacy faculty members with
THE CLINICAL PHARMACIST AS PRINCIPAL INVESTIGATOR ACCP either a Pharm.D. or Ph.D. degree received more than 600 NIH awards in FY 2004, representing a 59% increase from 1998 and a 153% increase in NIH funding from1998 to 2004. 13, 14 The findings provided in the AACP reports are supported by Touchette and colleagues,15 who found a non-significant 6.3% increase in the results of federally funded research grants published by pharmacists in clinical journals from 1993 to 2003. Growth in Funding and Publication of Research by Clinical Pharmacists Funding from the pharmaceutical industry remained the most common source of grant support to clinical pharmacists through 2003.15 A survey conducted by the ACCP Research Affairs Committee in 2003 found that 40% of ACCP member respondents had been awarded a research grant, with 60.0% of these grants from industry sources and 11.6% from the federal government. 3 Furthermore, 46.7% of respondents had published at least one original research article. The mean number of publications among respondents was reported to be 8.5 during the 1998–2003 survey period. The number of pharmacist-written research publications increased by 29.2% from 1993 to 2003, with 94.2% involving human subjects.15 Most pharmacist-directed research (about 70%) has been conducted in academic settings,15 but there is wide variation in publication rates by pharmacists in departments of pharmacy practice in the United States.15 NIH-Sponsored Conference on Pharm.D.s as Researchers As noted, few Pharm.D. clinical scientists have succeeded as PIs in receiving peer-reviewed research funding at the NIH. From the proceedings of the NIH conference on Pharm.D. Pathways to Biomedical Research in 2006, there appears to be a deficiency of opportunities and commitments to train, develop, and support Pharm.D. researchers. This deficiency contributes considerably to the gap in NIH funding for Pharm.D. clinical scientists as PIs. A summary of the conference can be found at http://www.nigms.nih.gov/Training/PharmD/.2, 16, 17 This conference provides a series of recommendations intended to increase the number of eligible and qualified clinical pharmacist researchers competing for extramural
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Some of the important NIH support. recommendations of this conference are exposure to research during the Pharm.D. curriculum and postgraduate training, highquality mentoring, grant writing experience and education, strong clinical practice skills, and participation in hypothesis-driven research. The extent to which these recommendations are acted on will likely critically influence clinical pharmacists’ research productivity. During the 2006 NIH conference on Pharm.D. Pathways to Biomedical Research, several presentations were made by NIH-funded pharmacist researchers. In developing this paper, we used www.PubMed.gov (U.S. National Library of Medicine) to search for publications by the eight NIH-funded conference faculty. (One faculty member did not have clear name differentiation and was excluded.) The number of publications for these conference Pharm.D. faculty ranged from a low of 117 citations to a high of 459 citations for seven of the eight presenters. Based on the collective experience of the committee, this level of publication is comparable to other non-Pharm.D. researchers. Data from ClinicalTrials.gov on Pharm.D. Researchers The committee searched for a mechanism to capture the number of clinical pharmacist PIs outside the federally funded system. In September 2007, federal laws were changed to require the registration of trials for FDAapproved (or cleared) phase II–IV drug and device trials at www.ClinicalTrials.gov. All NIHfunded clinical trials must be included in this database. Currently, www.ClinicalTrials.gov contains more than 70,000 trials and receives more than 40 million page views per month.18 To that end, the committee searched the expansive www.ClinicalTrials.gov database using three different forms of the term Pharm.D. (Pharm.D. OR Pharm.D OR PharmD). A total of 523 studies were found. Most (466) of the studies were interventional, compared with 57 observational studies. Table 1 shows the number of clinical studies stratified by funding category. The “snapshot in time” exemplifies the use of www.ClinicalTrials.gov to define the Pharm.D.’s role in clinical research. Few clinical trials appeared to involve Pharm.D.s; however, for those with Pharm.D. involvement, it is of interest that in most of the funding/sponsor categories listed in Table 2, the Pharm.D.’s role was that of
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PHARMACOTHERAPY Volume 30, December 2010 Table 1. Trials at www.ClinicalTrials.gov by category, with the number and percent including the search term (Pharm.D. OR Pharm.D OR PharmD)a Total of All Total No. with Total % with Studies in the Pharm.D. Pharm.D. Funding Source or Sponsor United States. Search Phrase Search Phrase Clinical research network 2206 14 0.6 Industry 15,423 307 2.0 NIH 13,462 79 0.5 U.S. federal agency excluding NIH 1776 14 0.8 Universities/organizations 18,357 231 1.3 Total 39,169 523 1.4 a Site accessed April 6, 2009. NIH = National Institutes of Health.
Table 2. Trials at www.ClinicalTrials.gov organized by sponsor, with the role of the Pharm.D. defineda Role of Pharm.D Sole One of two Study Site Studies with PI or more PIs Director/ PI Pharm.D. as Chair Funding Source or Sponsor Search Term Clinical research network 14 0 0 4 2 Industry 307 32 7 34 0 (100 analyzed) NIH 79 36 7 11 5 U.S. federal agency 14 6 1 excluding NIH Universities/foundations 231 57 13 (100 analyzed)
Contact Person or Other Role 8 27 20 7 30
a
Site accessed April 6, 2009. NIH = National Institutes of Health; PI = principal investigator.
PI in about one-third to one-half, modestly more than the role as contact person or subinvestigator. The ClinicalTrials.gov Web site divides studies within various domains. Overall, the number of studies that contained the Pharm.D. search term phrase as above was between 0.5% and 2% of the total in each category. Although these data provide important insight into pharmacist-directed research productivity, it remains difficult to determine the extent of pharmacists’ activity as PIs. The AACP report statistics do not account for pharmacist grant recipients who hold primary appointments in medical schools, cancer centers, or the NIH intramural program.17 Clinical pharmacists may not be the primary investigator of a research grant; rather, they may serve as project directors or serve in other investigator roles of subawards. Because of this limitation, a significant component of the multi-investigator collaborative project profile of investigator identity and status may be missed. Such data are not typically
considered in reports of funding awarded to pharmacists as PIs. Furthermore, databases of pharmacists who serve as PIs in research studies are not readily available or accessible. Exceptions to these generalizations are those listed in www.ClinicalTrials.gov. Notwithstanding, the productivity of pharmacists in research-funded publications is a useful surrogate of pharmacists’ activities as PIs. The establishment of Clinical and Translational Science Awards in 2006 promoted research models and structures that would provide new opportunities for colleges of pharmacy to collaborate with schools of medicine that foster interdisciplinary relationships.2, 3 Through these partnerships or graduate programs of colleges of pharmacy, master’s or doctoral graduate programs for developing clinical scientists are needed. 4 All Pharm.D. students should be introduced to clinical and translational research during the curriculum.4 Pharmacy will need to either maintain or increase its focus on
THE CLINICAL PHARMACIST AS PRINCIPAL INVESTIGATOR ACCP pharmacist-directed research to maintain the trajectory of research apparent during the past 50 years. Conclusions The clinical pharmacist has been accepted as a PI by many granting regulatory agencies and the pharmaceutical industry for several years. Further efforts are needed to ensure that the profession of pharmacy understands the need to continue the important contributions to training, educating, and expanding the efforts of those engaged in research. This responsibility begins within our pharmacy schools because all pharmacy graduates have a terminal doctoral degree. Faculty and clinical pharmacist research development efforts should be enhanced to ensure an adequate number of clinical scientists for the profession and to ensure the appropriate use of medications. Clinical pharmacists should continue their research development to ensure the provision of optimal, evidenced-based medication therapy based on sound scientific principles and research data. Finally, a reliable database should be established if the profession is serious about tracking statistics relative to clinical pharmacist funding, publications, and roles as PIs or subinvestigators in basic, clinical, and translational research.
4. 5. 6. 7. 8.
9. 10. 11.
12. 13. 14.
15.
References 1. ACCP. The clinical pharmacist as a principal investigator: a commentary from the American College of Clinical Pharmacy. Pharmacotherapy 2000;20:599–608. 2. Figg WD, Chan CH, Okita R, et al. Pharm.D. pathways to biomedical research: the National Institutes of Health special conference on pharmacy research. Pharmacotherapy 2008;28:821–33. 3. Fagan SC, Touchette D, Smith JA, et al. The state of science
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and research in clinical pharmacy. Pharmacotherapy 2006;26:1027–40. Blouin RA, Bergstrom RF, Ellengrod VL, et al. Report of the AACP Educating Clinical Scientists Task Force. Am J Pharm Educ 2007;71:Article S05. Carter BL, Blouin RA, Chewning BA, et al. Report of the AACP Educating Clinical Scientists Task Force II. Am J Pharm Educ 2008;72(Suppl):Article S10. Dowling TC, Murphy JE, Kalus JS, et al. ACCP commentary: recommended education for pharmacists as competitive clinical scientists. Pharmacotherapy 2009;29:236–44. Blouin RA, Pollack GM. Training clinical pharmaceutical scientists in today’s highly competitive times: it’s time to commit to change. Pharmacotherapy 2009;29:134–7. Bauman JL, Evans WE. Pharm.D.-only investigators are critical to the profession: let’s preserve the fellowship as an equally important way to prepare future clinical pharmaceutical scientists, or the case against the “all-Ph.D” (editorial). Pharmacotherapy 2009;29:129–33. Millis JS, Biles J, Chalmers R, et al. Pharmacists for the Future: The Report of the Study Commission on Pharmacy. Ann Arbor, MI: Health Administration Press, 1975:123–5. Nightingale SL. Clinical pharmacists as principal investigators (letter). Drug Intell Clin Pharm 1983;17:676. U.S. Food and Drug Administration. Guidance on Good Clinical Practice. April 1996. Available from http://www.fda.gov/downloads/Drugs/GuidanceComplianceReg ulatoryInformation/Guidances/ucm073122.pdf. Accessed May 12, 2010. European Medicines Agency. Guideline for Good Clinical Practice. July 2002. Available from http://www.emea.europa.eu/ pdfs/human/ich/013595en.pdf. Accessed May 12, 2010. Miller KW. The elephant in the room: NIH funding of facultyinitiated award proposals. Am J Pharm Educ 2006;70:Article 16. AACP Institutional Research Brief. Research Brief Volume 4. Available from http://www.aacp.org/resources/research /institutionalresearch/Documents/Brief_4.pdf. Accessed May 12, 2010. Touchette DR, Bearden DT, Ottum SA. Research publications by pharmacist authors in medical journals: changes over a 10year interval. Pharmacotherapy 2008;28:584–90. Figg WD. The Pharm.D. investigator in clinical pharmacology: supply and demand. Clin Pharmacol Ther 2008;84:526–9. Cohen JL. The PharmD investigator in clinical pharmacology: supply and demand. Clin Pharmacol Ther 2008;84:445–7. Update on clinical trials registration and results reporting requirements. Available from http://fsi.stanford.edu/news/ deborah_zarin_director_of_clinicaltrialsgov_addresses_chppcor _community_20090225/. Accessed May 12, 2010.
